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This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SY-201 Ophthalmic Solution 2.0% | Experimental | SY-201 Ophthalmic Solution 2.0% |
|
| SY-201 Ophthalmic Solution 1.0% | Experimental | SY-201 Ophthalmic Solution 1.0% |
|
| SY-201 Ophthalmic Solution 0.5% | Experimental | SY-201 Ophthalmic Solution 0.5% |
|
| SY-201 Ophthalmic Solution Vehicle | Placebo Comparator | SY-201 Ophthalmic Solution Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SY-201 Ophthalmic Solution 2.0% | Drug | SY-201 Ophthalmic Solution 2.0% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 | Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20). | 60 days |
| Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60 | Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60 | Cornea is divided into 5 regions. The central region is graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). | 60 days |
| Change From Baseline in Symptom Severity Score (Subscale) at Day 60 |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexitas | Durham | North Carolina | 27703 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SY-201 Ophthalmic Solution 2.0% | SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0% |
| FG001 | SY-201 Ophthalmic Solution 1.0% | SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0% |
| FG002 | SY-201 Ophthalmic Solution 0.5% | SY-201 Ophthalmic Solution 0.5%: SY-201 Ophthalmic Solution 0.5% |
| FG003 | SY-201 Ophthalmic Solution Vehicle | SY-201 Ophthalmic Solution Vehicle: SY-201 Ophthalmic Solution Vehicle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SY-201 Ophthalmic Solution 2.0% | SY-201 Ophthalmic Solution 2.0% SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0% |
| BG001 | SY-201 Ophthalmic Solution 1.0% | SY-201 Ophthalmic Solution 1.0% SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 | Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20). | Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations. | Posted | Mean | Standard Deviation | tCFS score on a scale of 0 - 20 | 60 days | Study Eyes | Study Eyes |
|
60 days
Complies with clinicaltrials.gov definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SY-201 Ophthalmic Solution 2.0% | SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Disorders | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jing-Feng Huang, Ph.D. | Seinda | 1.858.254.9188 | jfhuang@SeindaPharm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 13, 2022 | Oct 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2023 | Oct 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Double-masked, parallel, randomized
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
| SY-201 Ophthalmic Solution 1.0% |
| Drug |
SY-201 Ophthalmic Solution 1.0% |
|
| SY-201 Ophthalmic Solution 0.5% | Drug | SY-201 Ophthalmic Solution 0.5% |
|
| SY-201 Ophthalmic Solution Vehicle | Drug | SY-201 Ophthalmic Solution Vehicle |
|
Symptom severity score sub scale is measured of severity scale of symptoms associated with dry eye using visual analog scale (0 (none) -100 (severe)). This self reported Dry eye symptoms severity score sub scale measures the extent of any ocular discomfort (symptoms), including but not limited to dryness, ocular pain or other type of symptoms. |
| 60 days |
| BG002 | SY-201 Ophthalmic Solution 0.5% | SY-201 Ophthalmic Solution 0.5% SY-201 Ophthalmic Solution 0.5%: SY-201 Ophthalmic Solution 0.5% |
| BG003 | SY-201 Ophthalmic Solution Vehicle | SY-201 Ophthalmic Solution Vehicle SY-201 Ophthalmic Solution Vehicle: SY-201 Ophthalmic Solution Vehicle |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| SY-201 Ophthalmic Solution 1.0% |
SY-201 Ophthalmic Solution 1.0% SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0% |
| OG002 | SY-201 Ophthalmic Solution 0.5% | SY-201 Ophthalmic Solution 0.5%: SY-201 Ophthalmic Solution 0.5% |
| OG003 | SY-201 Ophthalmic Solution Vehicle | SY-201 Ophthalmic Solution Vehicle: SY-201 Ophthalmic Solution Vehicle |
|
|
| Primary | Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60 | Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness. | Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations. | Posted | Mean | Standard Deviation | Score on visual analog scale (0 -100) | 60 days |
|
|
|
| Secondary | Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60 | Cornea is divided into 5 regions. The central region is graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). | Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations. | Posted | Mean | Standard Deviation | Score on a scale of cCFS (mNEI: 0 - 4) | 60 days | Study Eyes | Study Eyes |
|
|
|
| Secondary | Change From Baseline in Symptom Severity Score (Subscale) at Day 60 | Symptom severity score sub scale is measured of severity scale of symptoms associated with dry eye using visual analog scale (0 (none) -100 (severe)). This self reported Dry eye symptoms severity score sub scale measures the extent of any ocular discomfort (symptoms), including but not limited to dryness, ocular pain or other type of symptoms. | Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations. | Posted | Mean | Standard Deviation | units on a scale 0-100 | 60 days |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 8 |
| 49 |
| EG001 | SY-201 Ophthalmic Solution 1.0% | SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0% | 0 | 51 | 0 | 51 | 3 | 51 |
| EG002 | SY-201 Ophthalmic Solution 0.5% | SY-201 Ophthalmic Solution 0.5%: SY-201 Ophthalmic Solution 0.5% | 0 | 50 | 0 | 50 | 4 | 50 |
| EG003 | SY-201 Ophthalmic Solution Vehicle | SY-201 Ophthalmic Solution Vehicle: SY-201 Ophthalmic Solution Vehicle | 0 | 48 | 0 | 48 | 4 | 48 |
| Instillation site irritation | General disorders | MedDRA (25.0) | Systematic Assessment |
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Collaborative and collegial interaction on presentations and publications.
| Study Eyes |
|